At the WPC 2019 in Kyoto we presented an abstract on the Registry for the Advancement of DBS for Parkinson’s Disease (RAD-PD) project.  This project was designed to build a comprehensive patient registry of DBS cases that can be tracked from their pre-operative visits, through to follow-up 5 years post-surgery.  It’s also designed to capture and analyze the full array of clinical data, including visualization of DBS electrode placement.

The past year has been a story of progress, but significantly slowed due to both internal and external challenges.  Internally, we had been relying on new database and analytical software that was late in becoming fully functional.  As a result, we have had to handle patient intake using paper and pencil forms, which will later be incorporated into a new data management system.  (Sounds like the US election system going to mail-in ballots!)  Fortunately, through the hard work of our study-site coordinators, we have continued study visits and new enrollments, albeit on a significantly slower pace (see below).  At the moment, we are focusing our efforts on finding / developing a platform that can handle brain images, along with the results of such instruments as the MDS UPDRS, Beck Depression Inventory, and others.  We expect to have made our choice and tested its functionality by the end of September 2020.

While our internal challenges have not interrupted our recruitment and tracking activities, external forces related to the Covid-19 pandemic have had a major impact on our project.  The influx of new DBS patients has slowed dramatically across the country, with most centers considering DBS an elective surgery that can be deferred until after the pandemic passes.  Patients who have already received DBS treatment can be monitored remotely, but obviously, many of the direct observation tools cannot be used.  For example, my neurologist asked me during a video call to summarize how my movements and symptoms were doing, and we set up a “course” where I could do the timed “up-and-go” test. However, we couldn’t do a full UPDRS, or other physician-rated assessments. 

The pandemic has put a complete hold on our being able to fully on-board new sites – we now stand at 10 sites already able to actively recruit patients, with another 10 centers capable of activation in the coming month.  However, none of these 20 centers can enroll patients as long as the pandemic limits the flow of new DBS patients into the system.  As noted above, we very much appreciate the efforts of the site teams to overcome our data handling slow-down, especially given the external forces interfering with our process at the same time.  Finally, it’s worth noting that our co-principal investigator, Dr. Joohi Jimenez-Shahed, recently returned from full-time, front-line clinical duty at Mount Sinai Hospital in New York City.

What we have learned from our initial analyses of admittedly limited information is that capture of a combination of clinician-measured and patient-reported data in a registry of DBS patients is possible and that patient characteristics and the approach to DBS management can indeed be heterogeneous. With this experience along with an updated data platform, we are confident that we will be able to characterize these differences, and achieve our goals of quality improvement in DBS for PD. We remain grateful to the Michael J Fox Foundation for their support of this project and look forward to sharing more definitive findings as they become available in the near future.

by James C. Kirk, Joohi Jimenez-Shahed, MD from Mount Sinai Medical Center and James McInerney, MD from Penn State Medical Center.

This research was first shared as an abstract at the WPC 2019 in Kyoto. WPC is pleased to support abstract authors by sharing their ongoing work. Digital files of WPC abstract books can be downloaded from the past three Congresses HERE.

Ideas and opinions expressed in this post reflect that of the author(s) solely. They do not necessarily reflect the opinions of the World Parkinson Coalition®